Post-marketing Surveillance of Spesolimab I.V. Infusion in improvement of Generalized Pustular Psoriasis (GPP) with acute symptoms in Japan (PMS for GPP with acute symptoms)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  SPEVIGO
• Medical condition to be studied:
  Pustular psoriasis
• Additional medical condition(s):
  acute symptoms of generalized pustular psoriasis

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  40

Study design details

• Main study objective:
  The primary outcome is the incidence of investigator/BI-defined drug reactions (including safety concerns: Serious infections, Serious hypersensitivity).
• Outcomes:
  The incidence of adverse drug reactions (ADRs)
• Data analysis plan:
  analyses are descriptive in nature, including confidence intervals.